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U.S. Department of Health and Human Services

Class 3 Device Recall Rubella IgG ELISA Kit

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 Class 3 Device Recall Rubella IgG ELISA Kitsee related information
Date Initiated by FirmDecember 16, 2009
Date PostedMarch 02, 2010
Recall Status1 Terminated 3 on March 29, 2012
Recall NumberZ-0922-2010
Recall Event ID 54124
510(K)NumberK960367 
Product Classification enzyme linked immunoabsorbent assay, rubella - Product Code LFX
ProductDiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28.
Code Information Lot 123127A
FEI Number 2182595
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall		DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results.
FDA Determined
Cause 2		Employee error
ActionConsignees were sent a DiaSorin Customer Notification letter dated December 16, 2009. The Letter was addressed to Customer. The letter described the product and the problem and indicated a replacement product will be provided. Requested consignees to complete the acknowledgement receipt form. For questions or concerns please contact DiaSorin Inc., Technical Services at 1-800-328-1482 or 651-439-9710.
Quantity in Commerce10 kits
DistributionUS distribution: CA, CT, MA, MD, IL, OR
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LFX
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